Identity
- Trade Name
- otosil ES-1.1 EUDAMEDFDA UDI
- Generic Name
- Earmould, custom-made FDA UDI
- Device Name
- ES-1.1 / 60 Shore neon-yellow opaque 8 double cartridges with 48 ml each FDA UDIES-1.1 / 60 Shore violet 8 double cartridges with 48 ml each FDA UDI
- Model / Reference
- 12140202 EUDAMEDA0033004 EUDAMEDShore 60 / 8 double cartridges of 2 x 24 ml - neon-yellow opaque FDA UDIShore 60 / 8 double cartridges of 2 x 24 ml - violet FDA UDI
- Description
- ES-1.1 / 60 Shore neon-yellow opaque 8 double cartridges with 48 ml each FDA UDIES-1.1 / 60 Shore violet 8 double cartridges with 48 ml each FDA UDI
Identifiers
- Catalog Number
- A0033529 FDA UDIA0033004 FDA UDI
- Primary DI / UDI-DI
- EPRCA0033004 EUDAMEDFDA UDIEPRCA0033529 FDA UDI
- Basic UDI-DI
- ++EPRC12140202BH EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Earmould, custom-made FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Earmould, custom-made
otosil ES-1.1 by Pro3Dure Medical — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pro3Dure Medical
Sources (3)
- FDA UDI e4949ed2-f52b-42e0-bff4-1b67a9e35380 35 fields · synced Jul 8, 2026
- FDA UDI 1dd9face-1ea5-41d8-9b7f-5432ffac37a0 35 fields · synced May 29, 2026
- EUDAMED 96502dcd-9e1c-4e77-9d53-2dbfbcbf948c 61 fields · synced Jul 8, 2026